2022-503004-24-00招募中3 期
A Phase 3/3b, Randomized, Observer-blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Subunit Inactivated Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 21,200
- 试验地点
- 62
- 主要终点
- First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition.
研究概览
简要总结
To demonstrate the efficacy of MF59-adjuvanted influenza vaccine in the prevention of RT-PCR-confirmed influenza A and/or B disease due to any influenza strain when compared to non-adjuvanted influenza vaccine in adults ≥65 years of age.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Adults of ≥65 years of age on the day of vaccination.
- •Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- •Individuals who have the ability to comply with study procedures including follow-up.
排除标准
- •Bedridden subjects (i.e. confined to bed by sickness or old age).
- •Abnormal function of the immune system resulting from: a. Clinical conditions; b. Systemic administration of corticosteroids (PO/IV/IM)8 at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted; c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent;
- •Receipt of immunoglobulins or any blood products within 180 days prior to informed consent;
- •Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
- •Acute (severe) febrile illness.
- •Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
- •Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.
- •Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
- •Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
- •Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
- •Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
- •Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
结局指标
主要结局
First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition.
First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition.
次要结局
- First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically matched to the vaccine strains selected for the seasonal vaccine, occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition.
- First-occurrence of culture-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination and until the end of influenza season, using the protocol-defined ILI definition.
- First-occurrence of RT-PCR-confirmed influenza, due to any influenza Type A and/or B virus (regardless of antigenic match), occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the modified CDC ILI definition as well as the WHO ILI definition.
- First-occurrence of culture-confirmed influenza, due to influenza Type A and/or B virus antigenically unmatched to the vaccine strains selected for the seasonal vaccine, occurring from 14 days after vaccination (ie study day 15) and until the end of influenza season, using the protocol-defined ILI definition
- The measures for immunogenicity as determined by the serum HI10 antibody titers for Day 1 and Day 22 for four vaccine homologous influenza strains are as follows for the subjects selected for the immunogenicity subset in each season – reference is made to the study protocol, page 75.
- Safety of the study vaccines will be assessed in all subjects in terms of the frequency of reported AEs including: • All AEs reported within 30 minutes after vaccination; • SAEs reported during the entire study period; • AESIs reported during the entire study period; • AEs leading to premature withdrawal from the study during the entire study period.
研究者
Seqirus UK Limited Clinical Trial Disclosures
Scientific
Seqirus UK Limited
研究点 (62)
Loading locations...
相似试验
已完成
3 期
A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of AgeInfluenza, HumanNCT06087640Seqirus38,769
已完成
不适用
Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System TumorsCentral Nervous System NeoplasmNCT01474174Wake Forest University Health Sciences38
已完成
2 期
CT18 Infant Influenza Priming Study in Vaccine Naive InfantsInfluenzaNCT03669627Canadian Immunization Research Network159
已完成
3 期
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and ElderlyInfluenzaNCT00492063Novartis Vaccines2,654
已完成
3 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)Pneumonia, PneumococcalNCT05526716Merck Sharp & Dohme LLC1,080